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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 16-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 16, 2008

Earnings
Biomet reported FQ1:09 revenues of $607.0 million, up 13% (9% constant currency) over the year-ago period. Excluding special charges, adjusted operating income was $171.6 million for FQ1:09, up 12% over FQ1:08. Among segments, reconstructive reported $449.3 million in sales, a 16% increase over the year ago period (12% constant currency), with knee sales increasing 20% (16% constant currency), hip increasing 18% (13% constant currency) and dental increasing 5% (-1% constant currency). Fixation sales were $60.2 million, an increase of 3% (1% constant currency) over the year-ago period. Spine sales were $51.3 million, a decrease of 4% (-6% constant currency) over FQ1:08.

Exactech, Inc. pre-announced 3Q:08 financial results this week, maintaining revenue estimates but lowering earnings estimates from a range of $0.21-$0.23 per diluted share to approximately $0.15 per diluted share due to higher than expected legal expenses relating to a previously announced DOJ inquiry.

Johnson & Johnson reported 3Q:08 revenue of $15.9 billion, an increase of 6% (3% constant currency) over the year-ago period and beating estimates by $0.2 billion. Net earnings and diluted earnings per share were $3.3 billion and $1.17, respectively, representing a 10% increase over the year-ago period and beating estimates by $0.05. DePuy reported revenues of $1.2 billion, a 10% (8% constant currency) increase over 3Q:07.

Stryker reported 3Q:08 net sales of $1.65 billion, in line with estimates and representing a 14% increase (12% constant currency) over 3Q:07. Net earnings were $273.8 million, a 20% increase over 3Q:07, and diluted net earnings per share were $0.66, missing estimates by a penny. The company reported $963.3 million in revenue from orthopedic implants, a 12% increase (10% constant currency) over 3Q:07. Among segments, hip revenues increased 6% (4% constant currency) over 3Q:07; knee revenues increased 16% (14% constant currency); trauma revenues increased 20% (16% constant currency); and spine revenues increased 21% (19% constant currency).

M&A
Interventional Spine announced plans to acquire all intellectual property, product prototypes and test data of the Percutaneous Nucleus Scaffolding System (PNSS) from Dr. Rudolf Morgenstern of the Morgenstern Institute of Endoscopic Spine Surgery in Barcelona. The company says when used with its PercuDyn System, PNSS can provide "a totally percutaneous procedure to replace the current highly invasive, open surgical total disc replacement procedure." No financial terms were disclosed.

Zimmer completed its acquisition of Abbott Spine, for which the company paid $360 million in cash in the transaction. Among Abbott's key products are the InCompass Pedicle Screw System; the Pathfinder Minimally Invasive Pedicle Screw system; the Wallis Interspinous Stabilizer System (available OUS); the Ant-Cer Dynamic Cervical Plate; and the Universal Clamp.

Regulatory
Amedica received 510(k) clearance to market the SEEplate Cervical Plate system, which is indicated for anterior screw fixation from C2 through C7 as an adjunct to cervical spine fusion.

Product Introduction & Update
DePuy Spine launched the BENGAL Stackable Cage System and the X-MESH Expandable Cage System. Both are VBR systems offering "multiple implant options for multi-level corpectomies."

DFine, Inc. launched the StabiliT Vertebral Augmentation System and StabiliT ER Bone Cement, which "allows for on-demand controlled delivery of a cohesive ultra-high viscosity cement in vertebral augmentation procedures." The company adds that physicians can control the viscosity of the StabiliT ER Bone Cement, a PMMA, through the application of radiofrequency energy.

Integra LifeSciences received 510(k) clearance to market Accell Evo3 in the U.S. Accell Evo3 is the company's "latest generation" in DBM and consists of a blend of particulate DBM, the proprietary Accell Bone Matrix (ABM) and a "unique poloxamer Reverse Phase Medium," which is described as a "thermo-reversible carrier that thickens at body temperature and is more flowable at room temperature."

ISTO Technologies, Inc. announced positive results from its preclinical animal study evaluating NuQu, a cell therapy derived from juvenile cartilage cells and designed as a non-invasive procedure for treatment of degenerative intervertebral disc. The study found that the treatment was able to "generate cartilage in the disc nucleus in a predictable and consistent basis."

Medtronic launched the X-Stop PEEK, an interspinous process decompression product designed to treat the symptoms of lumbar spinal stenosis. The company says that while similar to the X-Stop, the X-Stop PEEK features changes in material, shape and available sizes.

Pioneer Surgical Technology, Inc. launched the FortrOss bone graft substitute in the U.S. this week. The product consists of a combination of the company's nanOss hydroxyapatite with the E-Matrix scaffold.

Pioneer Surgical Technology, Inc. announced the first human implantation of its nanOss Cervical cage. The surgeries were performed in Beijing and Suzhou, China, on patients indicated for standard cervical fusion surgery using the nanOss-Cervical implant, bone graft material and anterior cervical plate.

VertiFlex launched the Silverbolt, a posterior fixation system designed to support percutaneous, mini-open and open procedures with a single instrument set.

Distribution
Pioneer Surgical Technology and Bonovo Orthopedics signed a distribution agreement whereby Bonovo will distribute Pioneer's products in China. Terms of the agreement were not disclosed. CEO Matthew Songer, MD, said, "The signing of this agreement with Bonovo Orthopedics is a milestone for our international expansion goals . . . Partnering with Bonovo secures the infrastructure and expertise necessary to be successful in the Chinese market."

Pioneer Surgical Technology's European subsidiary entered into a distribution agreement with Swedish Medical Imaging Devices AB, also known as Swemacimaging, whereby Pioneer Surgical Technology, BV will distribute the Biplanar 500e. The company describes the Biplanar as "the only mobile biplane digital fluoroscopy system." The agreement covers Germany, the United Kingdom, Italy, Benelux, Switzerland and Turkey. Financial terms were not disclosed.

Clinical
Facet Solutions, Inc. completed six-month follow-up on 20 patients from its IDE pilot study. Among the results: a 78% reduction in ODI scores and an 80% reduction in VAS scores for symptomatic leg pain.

Appointment
VertiFlex, Inc. appointed Catherine Kusnick, M.D. as Vice President, Medical and Clinical Affairs. Previously, Dr. Kusnick headed the Clinical Affairs departments at Interventional Spine, 3F Therapeutics and SenoRx.

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